FDA Folds

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 5 No. 6 • December 2002

In questions of power, let no more be heard of confidence in man, but bind him down from mischief by the chains of the Constitution.

— Thomas Jefferson

What a glorious morning this is!

— Samuel Adams, comment to John Hancock
at the Battle of Lexington, April 19, 1775

We have it in our power to begin the world over again.

— Thomas Paine, Common Sense, 1776

FDA Folds—The First Amendment Wins After 8 Years of Battle

It was indeed a glorious morning. On December 18, 2002, Ari Fleischer announced that the president and the new FDA commissioner, Mark McClellan, had met and were announcing that the FDA would be making available much more information about the health effects of dietary supplements, as well as foods, in a new FDA initiative called Better Health Information for Consumers. See www.cspan.com for the White House briefing by Ari Fleischer for Dec. 18, 2002.

On the same day, the FDA sent out a press release, “FDA Announces Initiative to Provide Better Health Information for Consumers,” which explained how health claims can be used in labels and in advertising that meet a new “weight of the scientific evidence” standard. (Up to now, the FDA has required health claims for foods or dietary supplements to meet an as yet undefined “significant scientific agreement” standard, which virtually demanded the near certainty of a scientific consensus.) The new qualified claim would require that the manufacturer provide a credible body of scientific data supporting the claim and show that the “weight of the scientific evidence” supports the claim. The FDA could require a disclaimer to prevent any potential misleading. The FDA press release can be downloaded from www.fda.gov/bbs/topics/NEWS/2002/NEW00859.html.

The FDA also issued, on December 18, a “Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements.” (Copies of this document can be obtained by calling 301-436-2317 or by faxing a request to 301-436-2636 or from the Internet at www.cfsan.fda.gov/~dms/guidance.html or www.fda.gov/ohrms/dockets/default.htm.)

In their “Guidance,” the FDA reviews the events leading up to this new policy. The FDA makes it clear that this major new policy change is intended to implement the court’s rulings in Pearson v. Shalala. The FDA’s new understanding of the requirements to meet Pearson are discussed in detail and is a 180º change from their prior willful misunderstanding. The proposed changes to the FDA health-claims process were those we had long been arguing for, most recently in a 160-page Public Comment submitted to the FDA in response to their call in the Federal Register for public comments on how the FDA could regulate labels and advertising and still comply with the First Amendment (our Public Comment is available at www.emord.com).

The most exciting part of this decision to bring the FDA into compliance with the First Amendment is a consideration of the changes that will quickly occur as a result. We will almost immediately see many petitions for health claims, both by dietary supplement and food companies. Reliable health information available to consumers in the marketplace will be increased manyfold in a few years. The availability of useful information on how to reduce the risks of medical conditions and manifestations of aging will provide much needed competition with the pharmaceutical industry. That industry will have to find new models for business than merely one in which profits are made by investing huge amounts of money in developing patented blockbuster drugs that are then sold at high prices as a monopoly for limited periods of time. For example, a health claim that omega-3 fatty acids (as found, for example, in coldwater fish oils) markedly reduce the risk of cardiovascular disease (CVD), especially sudden death from CVD, will allow competition with some CVD drugs on the market at much higher prices and with much greater potential for serious adverse side effects.

In ten years, we doubt that much will remain of the conventional foods that are most of what you find in a modern supermarket or fast food emporium. Instead you will find functional foods, that is, foods in which particular natural ingredients with healthful properties are increased and undesirables are reduced, either by fortification or by breeding or genetically engineering new and better forms of edible animals and plants. Biotechnology will win over consumers not by saving farmers money on pesticide use, but by making foods more healthful. For example, some scientists have already developed a tomato that contains greatly increased levels of lycopene, and we have reported previously on the high-amylose-starch potato created by genetic engineering that results in a slowly digested potato with a greatly reduced glucose spike.

In sum, this new policy will help create and expand a free market in medicine.

Loose ends? Yes, there always are some. We will not be finished with the FDA until it allows health claims for foods and dietary supplements that can be used to treat diseases, not just help prevent diseases. This, too, is a First Amendment issue. If information on a treatment use for a dietary supplement or food is truthful and nonmisleading, then the government has no authority to prohibit it. Yet the FDA still stands firm against such treatment claims. We can expect the pharmaceutical industry to continue to fight these claims. A suit has already been filed on these issues. A health-claims petition had originally been filed by Dr. Julian Whitaker, ourselves, and others that asked the FDA to approve a claim that saw palmetto could reduce the symptoms of mild benign prostatic hypertrophy. The claim is truthful and nonmisleading, yet the FDA refused even to review the claim, saying that this is a “treatment” claim and, hence, was not covered by the DSHEA’s provisions for health claims. The DSHEA, however, permits truthful claims for “any nutrient-disease relationship.” Moreover, if the Congressional statute did not permit truthful “treatment” claims, then it would be unconstitutional, being a violation of the First Amendment. The case, where we sued the FDA on both statutory and First Amendment grounds for its unwillingness to review the saw palmetto health claim, is now awaiting decision before a judge of the district court of the District of Columbia. If we lose, then we’ll appeal. Presumably the FDA will do the same if it loses. The final loose end is this: As we interpret it, the First Amendment (“Congress shall make no law . . . abridging the freedom of speech, or of the press . . .”) provides that we need no go-ahead or authorization or approval from the government in order to communicate truthful, nonmisleading information. We shouldn’t need to ask the FDA’s permission before speaking. But we feel that it will take another two or three Clarence Thomases—Clarence Thomas believes that “commercial speech” should receive as much First Amendment protection as any other kind of speech—on the U.S. Supreme Court before we can win this.

Our heartfelt thanks to our coplaintiffs,* especially Julian Whitaker, M.D., in this 8-year and continuing litigation effort and to Jonathan Emord for making this great victory possible with his brilliant legal skills and principled commitment to the First Amendment. Plus our special thanks to those of you who are not coplaintiffs but who donated money to help us pay for this protracted battle; we hope you will feel now that it was worth every penny. We are about to enter a wonderful new world where it will be far easier to live a very long and healthy life.

*See www.emord.com for the complete listing of plaintiffs for Pearson v. Shalala and follow-up cases.

Happy New Year!

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